Radium-223 + abiraterone acetate: a potential safety issue

Bayer is to unblind data early from an ongoing randomized clinical trial of radium-223 acetate — on the guidance of the trial’s Independent Data Monitoring Committee (IDMC). The company’ media release can be read in full if you click here.

The trial data that are being unblinded are from the Phase III clinical trial of radium-223 (Xofigo) + abiraterone acetate (Zytiga) + prednisone or prednisolone vs. a placebo + abiraterone acetate (Zytiga) + predisone or prednisolone in asymptomatic or minimally symptomatic men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). This trial is also known as the ERA223 trial.

The IDMC recommended that the trial data be unblinded early because there appears to be a clear signal that men randomized to treatment with the combination of Xofigo + Zytiga + prednisone or prednisolone have a higher incidence of fractures and deaths than those randomized to treatment with a placebo + Zytiga + prednisone or prednisolone.

Bayer notes that this problem has not been evident in any earlier trials that used combination therapy with Xofigo + Zytiga + prednisone or prednisolone. The current trial was fully enrolled and included a total of 806 patients.

Patient safety is our top priority. We are therefore unblinding the study to thoroughly analyze the data

according to Mike Devoy, a member of the Pharmaceuticals’ Division Executive Committee and the Chief Medical Officer at Bayer.

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